pirfenidone

Generic: pirfenidone

Labeler: laurus labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pirfenidone
Generic Name pirfenidone
Labeler laurus labs limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

pirfenidone 267 mg/1

Manufacturer
Laurus Labs Limited

Identifiers & Regulatory

Product NDC 42385-923
Product ID 42385-923_487408e2-1370-400a-a513-8de1d662defa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212724
Listing Expiration 2026-12-31
Marketing Start 2022-07-19

Pharmacologic Class

Established (EPC)
pyridone [epc]
Chemical Structure
pyridones [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42385923
Hyphenated Format 42385-923

Supplemental Identifiers

RxCUI
1592279 1868014 1868018 2606490 2606491
UPC
0342385923292
UNII
D7NLD2JX7U
NUI
N0000191420 M0018236

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name pirfenidone (source: ndc)
Generic Name pirfenidone (source: ndc)
Application Number ANDA212724 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 267 mg/1
source: ndc
Packaging
  • 270 CAPSULE in 1 BOTTLE (42385-923-29)
  • 4 BLISTER PACK in 1 CARTON (42385-923-54) / 63 CAPSULE in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (42385-923-63) / 21 BLISTER PACK in 1 BLISTER PACK / 42 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (3)

42385-923-29 270 CAPSULE in 1 BOTTLE (42385-923-29) 42385-923-54 4 BLISTER PACK in 1 CARTON (42385-923-54) / 63 CAPSULE in 1 BLISTER PACK 42385-923-63 2 BLISTER PACK in 1 CARTON (42385-923-63) / 21 BLISTER PACK in 1 BLISTER PACK / 42 CAPSULE in 1 BLISTER PACK

Ingredients (1)

pirfenidone (267 mg/1)

Linked Drug Pages (1)

Pirfenidone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "487408e2-1370-400a-a513-8de1d662defa", "openfda": {"nui": ["N0000191420", "M0018236"], "upc": ["0342385923292"], "unii": ["D7NLD2JX7U"], "rxcui": ["1592279", "1868014", "1868018", "2606490", "2606491"], "spl_set_id": ["29b0fd0e-5a2b-4da7-8524-177dc28bf55e"], "pharm_class_cs": ["Pyridones [CS]"], "pharm_class_epc": ["Pyridone [EPC]"], "manufacturer_name": ["Laurus Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "270 CAPSULE in 1 BOTTLE (42385-923-29)", "package_ndc": "42385-923-29", "marketing_start_date": "20220719"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (42385-923-54)  / 63 CAPSULE in 1 BLISTER PACK", "package_ndc": "42385-923-54", "marketing_start_date": "20220719"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (42385-923-63)  / 21 BLISTER PACK in 1 BLISTER PACK / 42 CAPSULE in 1 BLISTER PACK", "package_ndc": "42385-923-63", "marketing_start_date": "20220719"}], "brand_name": "Pirfenidone", "product_id": "42385-923_487408e2-1370-400a-a513-8de1d662defa", "dosage_form": "CAPSULE", "pharm_class": ["Pyridone [EPC]", "Pyridones [CS]"], "product_ndc": "42385-923", "generic_name": "Pirfenidone", "labeler_name": "Laurus Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pirfenidone", "active_ingredients": [{"name": "PIRFENIDONE", "strength": "267 mg/1"}], "application_number": "ANDA212724", "marketing_category": "ANDA", "marketing_start_date": "20220719", "listing_expiration_date": "20261231"}